FI3834841T3 - Stabiloituja neste- ja lyofilisoituja ADAMTS13-formulaatioita - Google Patents

Stabiloituja neste- ja lyofilisoituja ADAMTS13-formulaatioita Download PDF

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Publication number
FI3834841T3
FI3834841T3 FIEP20211228.0T FI20211228T FI3834841T3 FI 3834841 T3 FI3834841 T3 FI 3834841T3 FI 20211228 T FI20211228 T FI 20211228T FI 3834841 T3 FI3834841 T3 FI 3834841T3
Authority
FI
Finland
Prior art keywords
formulation according
formulation
adamts13
sugar
optionally
Prior art date
Application number
FIEP20211228.0T
Other languages
English (en)
Finnish (fi)
Inventor
H Matthiessen
Peter Turecek
Hans-Peter Schwarz
Original Assignee
Takeda Pharmaceuticals Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Takeda Pharmaceuticals Co filed Critical Takeda Pharmaceuticals Co
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Publication of FI3834841T3 publication Critical patent/FI3834841T3/fi

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/4886—Metalloendopeptidases (3.4.24), e.g. collagenase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/24—Metalloendopeptidases (3.4.24)
    • C12Y304/24087—ADAMTS13 endopeptidase (3.4.24.87)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • General Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Diabetes (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Medicinal Preparation (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Dispersion Chemistry (AREA)
  • Dermatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
FIEP20211228.0T 2009-09-21 2010-09-21 Stabiloituja neste- ja lyofilisoituja ADAMTS13-formulaatioita FI3834841T3 (fi)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US24435309P 2009-09-21 2009-09-21

Publications (1)

Publication Number Publication Date
FI3834841T3 true FI3834841T3 (fi) 2023-06-05

Family

ID=43598388

Family Applications (2)

Application Number Title Priority Date Filing Date
FIEP20211228.0T FI3834841T3 (fi) 2009-09-21 2010-09-21 Stabiloituja neste- ja lyofilisoituja ADAMTS13-formulaatioita
FIEP23172759.5T FI4218797T3 (fi) 2009-09-21 2010-09-21 Stabiloituja nestemäisiä ja kylmäkuivattuja adamts13-formulaatioita

Family Applications After (1)

Application Number Title Priority Date Filing Date
FIEP23172759.5T FI4218797T3 (fi) 2009-09-21 2010-09-21 Stabiloituja nestemäisiä ja kylmäkuivattuja adamts13-formulaatioita

Country Status (21)

Country Link
US (9) US8623352B2 (Direct)
EP (5) EP4467160A3 (Direct)
JP (2) JP5819303B2 (Direct)
KR (6) KR20210054598A (Direct)
CN (2) CN102573792B (Direct)
AU (1) AU2010295299B2 (Direct)
BR (1) BR112012006283B1 (Direct)
CA (1) CA2774556A1 (Direct)
DK (4) DK3167897T3 (Direct)
EA (1) EA024267B1 (Direct)
ES (4) ES2865250T3 (Direct)
FI (2) FI3834841T3 (Direct)
FR (1) FR24C1049I2 (Direct)
HR (1) HRP20160295T1 (Direct)
HU (1) HUE028688T2 (Direct)
IN (1) IN2012DN02645A (Direct)
MX (3) MX339205B (Direct)
NZ (1) NZ598839A (Direct)
PL (4) PL3167897T3 (Direct)
PT (2) PT4218797T (Direct)
WO (1) WO2011035335A2 (Direct)

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CN103566362B (zh) * 2012-07-21 2015-07-29 复旦大学 重组adamts13在制备脑出血药物中的用途
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AU2013203062C1 (en) * 2013-03-15 2018-06-28 Takeda Pharmaceutical Company Limited Subcutaneous administration of adamts13
US9587235B2 (en) 2013-03-15 2017-03-07 Atyr Pharma, Inc. Histidyl-tRNA synthetase-Fc conjugates
CA2952609A1 (en) * 2014-06-26 2015-12-30 Amgen Inc. Solid protein formulations comprising stabilizer, sugar alcohol, sugar and surfactant
GB201510870D0 (en) * 2015-05-26 2015-08-05 Baxalta Inc And Katholieke Universiteit Leuven And Baxalta Gmbh Treatment of infarction
ES2983978T3 (es) * 2016-01-08 2024-10-28 Univ Kyoto Medicina que comprende ADAMTS13 como ingrediente principal
EA201990373A1 (ru) * 2016-08-04 2019-07-31 Баксалта Инкорпорэйтед Применение adamts13 для лечения, уменьшения интенсивности и/или предупреждения вазоокклюзивного криза при серповидноклеточной анемии, остром повреждении легкого и/или остром респираторном дистресс-синдроме
PT3534922T (pt) 2016-11-04 2024-06-07 Takeda Pharmaceuticals Co Formulações de vírus adenoassociado
CN110536694A (zh) 2017-04-20 2019-12-03 Atyr 医药公司 用于治疗肺部炎症的组合物和方法
PL3639845T3 (pl) * 2017-07-25 2023-10-23 Jiangsu Hengrui Medicine Co., Ltd. Kompozycja farmaceutyczna zawierająca kompleks białka il-15 i jej zastosowania
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AU2021248679A1 (en) 2020-04-02 2022-10-27 Takeda Pharmaceutical Company Limited ADAMTS13 variant, compositions, and uses thereof
EP4153215A1 (en) 2020-05-22 2023-03-29 Takeda Pharmaceutical Company Limited Adamts13 compositions and methods for treating and diagnosing complications of coronavirus disease
EP4196147A4 (en) * 2020-08-13 2024-08-21 Hadasit Medical Research Services and Development Ltd. DISINTEGRIN AND METALLOPROTEINASE WITH THROMBOSPONDIN TYPE 1 MOTIF, MUTANTS OF ELEMENT 13 (ADAMTS-13), COMPOSITIONS AND THERAPEUTIC METHODS THEREFOR
WO2023170680A1 (en) 2022-03-08 2023-09-14 Equashield Medical Ltd Fluid transfer station in a robotic pharmaceutical preparation system
KR20240112755A (ko) * 2023-01-11 2024-07-19 주식회사 녹십자 혈전성 질환의 예방 또는 치료를 위한 신규한 액상 제형물

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Also Published As

Publication number Publication date
EP3167897B1 (en) 2021-01-27
EA201200519A1 (ru) 2012-09-28
EP3834841B1 (en) 2023-05-17
KR20190137954A (ko) 2019-12-11
PT3834841T (pt) 2023-06-19
BR112012006283A2 (pt) 2016-05-31
HUE028688T2 (en) 2017-01-30
EP4218797A1 (en) 2023-08-02
KR20180095738A (ko) 2018-08-27
EP4467160A2 (en) 2024-11-27
EP4218797B1 (en) 2024-09-11
FR24C1049I1 (fr) 2025-01-17
JP2013505270A (ja) 2013-02-14
KR20120099646A (ko) 2012-09-11
ES3001509T3 (en) 2025-03-05
WO2011035335A3 (en) 2011-12-01
PT4218797T (pt) 2024-12-09
US20170112906A1 (en) 2017-04-27
CN102573792B (zh) 2014-10-15
KR101891646B1 (ko) 2018-08-27
PL2480198T3 (pl) 2016-09-30
ES2948612T3 (es) 2023-09-14
HK1173968A1 (zh) 2013-05-31
US9937244B2 (en) 2018-04-10
US10238720B2 (en) 2019-03-26
PL3167897T3 (pl) 2021-09-27
ES2579906T3 (es) 2016-08-17
EP2480198B1 (en) 2016-03-09
US9351935B2 (en) 2016-05-31
US20230130866A1 (en) 2023-04-27
US9572778B2 (en) 2017-02-21
US20160375111A1 (en) 2016-12-29
CA2774556A1 (en) 2011-03-24
US11564979B2 (en) 2023-01-31
EP3167897A1 (en) 2017-05-17
NZ598839A (en) 2014-03-28
BR112012006283B1 (pt) 2022-03-15
MX2019000547A (es) 2020-11-12
EP2480198A2 (en) 2012-08-01
MX362382B (es) 2019-01-14
DK2480198T3 (en) 2016-03-29
PL3834841T3 (pl) 2023-07-24
CN102573792A (zh) 2012-07-11
CN104224705A (zh) 2014-12-24
DK4218797T3 (da) 2024-12-09
PL4218797T3 (pl) 2025-02-10
DK3167897T3 (da) 2021-04-19
EP3834841A1 (en) 2021-06-16
EP4218797B9 (en) 2025-04-30
US8623352B2 (en) 2014-01-07
JP5819303B2 (ja) 2015-11-24
US20190247475A1 (en) 2019-08-15
MX2012003414A (es) 2012-06-19
DK4218797T5 (da) 2025-07-21
US20110229455A1 (en) 2011-09-22
FI4218797T3 (fi) 2024-12-07
WO2011035335A2 (en) 2011-03-24
DK3834841T3 (da) 2023-06-06
JP2015063556A (ja) 2015-04-09
US20180207245A1 (en) 2018-07-26
US10758599B2 (en) 2020-09-01
KR20210054598A (ko) 2021-05-13
US20200376098A1 (en) 2020-12-03
US20140178357A1 (en) 2014-06-26
CN104224705B (zh) 2018-02-02
ES2865250T3 (es) 2021-10-15
FR24C1049I2 (fr) 2025-12-12
IN2012DN02645A (Direct) 2015-09-11
EP4467160A3 (en) 2025-01-15
US12178861B2 (en) 2024-12-31
AU2010295299B2 (en) 2015-12-24
EP2480198B9 (en) 2016-11-23
AU2010295299A1 (en) 2012-04-12
KR20220139456A (ko) 2022-10-14
EA024267B1 (ru) 2016-09-30
HRP20160295T1 (hr) 2016-05-20
US20250099559A1 (en) 2025-03-27
KR20250008986A (ko) 2025-01-16
MX339205B (es) 2016-05-16

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